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Overview
Job: Senior Process Engineer – Life Sciences (Fill/Finish Specialist) Location: Broomfield, CO | Lenexa, KS | Lynwood, WA | Remote George Butler Associates is a full-service architecture and engineering firm delivering compliant facilities for the biopharma ecosystem, supporting clients through conceptual planning, facility design, equipment procurement, utility engineering, automation design, and commissioning. We’re looking for a Senior-level process engineer with specialized fill/finish expertise to lead sterile drug product manufacturing facility projects for pharmaceutical, biotechnology, animal health, and ATMP sectors. Role encompasses design through construction documentation, client management, and team leadership.
What You’ll Do
Lead design efforts and prepare construction drawings and contract documents
Develop process design documentation including PFDs, P&IDs, piping layouts, and equipment specifications
Perform equipment sizing, mass/energy balances, and engineering calculations
Manage capital projects from concept through commissioning and qualification
Lead cross-disciplinary teams and delegate tasks to junior engineers
Provide technical leadership in fill/finish operations including:
Aseptic filling machines (vial, syringe, cartridge, bag systems)
Lyophilizers and freeze-drying systems
Isolator and RABS technology
Capping, sealing, inspection, and packaging equipment
Serialization systems
Interface with equipment vendors and support validation activities (IQ, OQ, PQ)
Engage with clients through workshops, field investigations, and technical documentation
Support marketing efforts and proposal development
Conduct feasibility studies, process simulations, and risk assessments
Mentor junior engineers and contribute to professional development initiatives
What You Bring
Bachelor’s degree in Chemical, Biochemical, or Mechanical Engineering (Master’s preferred)
10+ years of biopharmaceutical process engineering experience with a strong background in fill/finish and aseptic processing
Experience with A&E consulting or pharmaceutical manufacturing preferred
Proven leadership in design projects from concept to construction
Expertise in:
Aseptic processing and sterile drug product manufacturing
Fill/finish equipment design, specification, and qualification
Cleanroom design and contamination control strategies
Utility systems (WFI, clean steam, compressed air)
Strong engineering fundamentals and familiarity with tools such as SchedulePro, FlexSim, AutoCAD, Revit, Bluebeam, AFT Fathom, and AFT Arrow
PE license preferred or ability to obtain within 2 years
Knowledge of FDA, EMA, ICH guidelines, ISPE Baseline Guides, and GMP requirements
Experience with PHA, HAZOP, and risk assessment methodologies
Excellent communication, problem-solving, and leadership skills
Physical Requirements
Ability to lift up to 15 pounds
Conduct fieldwork and navigate active construction sites
Work in cleanroom environments including Grade A/ISO 5 aseptic areas
Travel This position requires 10–20% travel to project sites, client meetings, and industry events.
Why You’ll Love Working Here
Competitive salary: $120,000 – $170,000 annually + performance bonus
Medical, dental, and vision insurance
Life, accident, and disability coverage
401(k) with company match
Employee Assistance Program (EAP) and wellness initiatives
Paid company holidays, floating holidays, and flexible time off
Professional development budget, conference attendance, and leadership programs
Clear advancement pathway and mentorship opportunities
Join Our Team If you’re a motivated engineering professional who takes pride in leading safe, high-quality projects, we’d love to hear from you.
Apply today and build your future with GBA.
At GBA, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.
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Job: Senior Process Engineer – Life Sciences (Fill/Finish Specialist) Location: Broomfield, CO | Lenexa, KS | Lynwood, WA | Remote George Butler Associates is a full-service architecture and engineering firm delivering compliant facilities for the biopharma ecosystem, supporting clients through conceptual planning, facility design, equipment procurement, utility engineering, automation design, and commissioning. We’re looking for a Senior-level process engineer with specialized fill/finish expertise to lead sterile drug product manufacturing facility projects for pharmaceutical, biotechnology, animal health, and ATMP sectors. Role encompasses design through construction documentation, client management, and team leadership.
What You’ll Do
Lead design efforts and prepare construction drawings and contract documents
Develop process design documentation including PFDs, P&IDs, piping layouts, and equipment specifications
Perform equipment sizing, mass/energy balances, and engineering calculations
Manage capital projects from concept through commissioning and qualification
Lead cross-disciplinary teams and delegate tasks to junior engineers
Provide technical leadership in fill/finish operations including:
Aseptic filling machines (vial, syringe, cartridge, bag systems)
Lyophilizers and freeze-drying systems
Isolator and RABS technology
Capping, sealing, inspection, and packaging equipment
Serialization systems
Interface with equipment vendors and support validation activities (IQ, OQ, PQ)
Engage with clients through workshops, field investigations, and technical documentation
Support marketing efforts and proposal development
Conduct feasibility studies, process simulations, and risk assessments
Mentor junior engineers and contribute to professional development initiatives
What You Bring
Bachelor’s degree in Chemical, Biochemical, or Mechanical Engineering (Master’s preferred)
10+ years of biopharmaceutical process engineering experience with a strong background in fill/finish and aseptic processing
Experience with A&E consulting or pharmaceutical manufacturing preferred
Proven leadership in design projects from concept to construction
Expertise in:
Aseptic processing and sterile drug product manufacturing
Fill/finish equipment design, specification, and qualification
Cleanroom design and contamination control strategies
Utility systems (WFI, clean steam, compressed air)
Strong engineering fundamentals and familiarity with tools such as SchedulePro, FlexSim, AutoCAD, Revit, Bluebeam, AFT Fathom, and AFT Arrow
PE license preferred or ability to obtain within 2 years
Knowledge of FDA, EMA, ICH guidelines, ISPE Baseline Guides, and GMP requirements
Experience with PHA, HAZOP, and risk assessment methodologies
Excellent communication, problem-solving, and leadership skills
Physical Requirements
Ability to lift up to 15 pounds
Conduct fieldwork and navigate active construction sites
Work in cleanroom environments including Grade A/ISO 5 aseptic areas
Travel This position requires 10–20% travel to project sites, client meetings, and industry events.
Why You’ll Love Working Here
Competitive salary: $120,000 – $170,000 annually + performance bonus
Medical, dental, and vision insurance
Life, accident, and disability coverage
401(k) with company match
Employee Assistance Program (EAP) and wellness initiatives
Paid company holidays, floating holidays, and flexible time off
Professional development budget, conference attendance, and leadership programs
Clear advancement pathway and mentorship opportunities
Join Our Team If you’re a motivated engineering professional who takes pride in leading safe, high-quality projects, we’d love to hear from you.
Apply today and build your future with GBA.
At GBA, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.
#J-18808-Ljbffr